Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renee Stapleton, University of Vermont
ClinicalTrials.gov Identifier:
NCT01558817
First received: February 21, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly in patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic cancer. Recent work found that in-hospital CPR is being performed more often before death with unchanging survival and that fewer CPR survivors are being discharged home, thus suggesting that CPR is increasingly performed without benefit and that the burden of this ineffective treatment is increasing. Unlike other medical procedures, CPR has become the default provided to all patients even those with tremendously poor outcomes. It is time to change the paradigm of CPR. Through comparing an innovative "informed assent" approach toward in-hospital CPR (informing patients that their underlying chronic illness makes outcomes of CPR so poor that CPR is not performed while allowing them to disagree) versus usual care in a group of chronically ill patients with reduced life expectancy, the investigators aspire to demonstrate that CPR delivery can be reduced. And in addition that DNR status increases, while preserving patient quality of life and decreasing the burden of this ineffective treatment to both patients and families. If effective, this informed assent intervention has the potential to revolutionize how the investigators discuss CPR with the investigators chronically ill patients.


Condition Intervention
Oxygen Dependent COPD
Advanced Malignancy
Behavioral: Informed Assent
Behavioral: Informational Brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Cardiopulmonary Resuscitation Preference [ Time Frame: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention ] [ Designated as safety issue: No ]
    The primary outcome will be the difference in the proportion of patients in the informed assent intervention and informational brochure groups reporting preferences to be DNR (do not rescusitate).


Secondary Outcome Measures:
  • Depression [ Time Frame: Baseline (day of intervention) and 2 weeks after intervention ] [ Designated as safety issue: No ]
    Patients' and family members' symptomes of depression will be measured by the PHQ-8 questionnaire.

  • Anxiety [ Time Frame: Baseline (day of intervention) and two weeks after intervention ] [ Designated as safety issue: No ]
    Patients and families will complete the GAD-7 questionnaire, a measure of generalized anxiety disorder.

  • Physician Order for Life Sustaining Treatment (POLST) [ Time Frame: Baseline (day of intervention) and 2 weeks after intervention ] [ Designated as safety issue: No ]
    Participants who expressed a preference to be DNR will be asked to complete a POLST form by their physician. It will also be explained that this can be changed any time the status changes.

  • DNR status preference [ Time Frame: Two weeks after the intervention ] [ Designated as safety issue: No ]
    The difference in DNR status preference between patients in the control and invervention group at two weeks after the intervention.

  • Report on acceptability of the informed assent approach [ Time Frame: Within couple of hours (up to 2 weeks) after intervention ] [ Designated as safety issue: No ]

    The following questions will be asked:

    1. How helpful was this approach to discussing CPR with respect to CPR decisions?
    2. Would you recommend this approach to discussing CPR for other patients who have serious illnesses?

  • Assessment of DNR status change or intervention follow-up from primary physician [ Time Frame: Three months after the intervention ] [ Designated as safety issue: No ]
    Contact the physician for each patient at 3 months after the study visit to determine whether there are changes in the DNR status or if the physician has talked with the patients about the status since the study visit.

  • Resource utilization [ Time Frame: Up to 6 months after intervention or until death ] [ Designated as safety issue: No ]
    Record resource utilization for participants that includes hospitalizations, ICU care, use of hospice etc by medical record review.


Enrollment: 29
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Informational brochure
Patients receive an informational brochure
Behavioral: Informational Brochure
An informational brochure about CPR will be given without a discussion with a physician.
Experimental: Intervention
Patients receive physician-directed informed assent intervention regarding CPR and informational brochure.
Behavioral: Informed Assent
Patients receive informed assent approach toward in-hospital CPR outcomes. Patients are informed that their underlying chronic illness makes outcomes after CPR so poor that CPR is not performed while allowing them to disagree.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Oxygen dependent COPD or Advanced Malignancy
  • Life expectancy of less than two years

Exclusion Criteria:

  • Subjects who have already firmly decided to undergo CPR
  • Subjects enrolled in a hospice program
  • Subjects unable to speak English
  • Subjects incapable of making their own decisions at the time of enrollment
  • Subjects cared for by the study investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558817

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Vermont
University of Vermont and Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Vermont
  More Information

No publications provided

Responsible Party: Renee Stapleton, Associatet Professor, Pulmonary and Critical Care Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT01558817     History of Changes
Other Study ID Numbers: PilotCPR001
Study First Received: February 21, 2012
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
CPR
Palliative
Outcome

ClinicalTrials.gov processed this record on October 23, 2014